The
Committee consisted of the following
Members:
Chairman:
Mr.
Christopher
Chope
†
Burrowes,
Mr. David
(Enfield, Southgate)
(Con)
Carswell,
Mr. Douglas
(Harwich)
(Con)
†
Clarke,
Mr. Charles
(Norwich, South)
(Lab)
†
Creagh,
Mary
(Wakefield)
(Lab)
†
Cryer,
Mrs. Ann
(Keighley)
(Lab)
†
Devine,
Mr. Jim
(Livingston)
(Lab)
Hands,
Mr. Greg
(Hammersmith and Fulham)
(Con)
†
Harris,
Dr. Evan
(Oxford, West and Abingdon)
(LD)
†
Jones,
Mr. Kevan
(North Durham)
(Lab)
†
Lamb,
Norman
(North Norfolk)
(LD)
†
McCarthy,
Kerry
(Bristol, East)
(Lab)
†
Murrison,
Dr. Andrew
(Westbury)
(Con)
†
Rosindell,
Andrew
(Romford)
(Con)
†
Ward,
Claire
(Lord Commissioner of Her Majesty's
Treasury)
Watson,
Mr. Tom
(West Bromwich, East)
(Lab)
†
Whitehead,
Dr. Alan
(Southampton, Test)
(Lab)
†
Winterton,
Ms Rosie
(Minister of State, Department of
Health)
Emily
Commander, Committee
Clerk
†
attended the Committee
First
Delegated Legislation
Committee
Monday 21 May
2007
[Mr.
Christopher Chope
in the
Chair]
Draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007
4.30
pm
The
Minister of State, Department of Health
(Ms Rosie Winterton):
I beg to
move,
That
the Committee has considered the draft Human Fertilisation and
Embryology (Quality and Safety) Regulations
2007.
The
Chairman:
With this it will be convenient to consider the
draft Human Tissue (Quality and Safety for Human Application)
Regulations
2007.
Ms
Winterton:
It is a pleasure to serve under your
chairmanship, Mr. Chope. The regulations provide an
important opportunity to introduce a harmonised
regulatory framework in the United Kingdom to ensure the quality and
safety of tissues and cells intended for transplantation and other
human applications. They will contribute to the introduction of safety
standards across the European Union, facilitating safer and easier
exchange of tissues and cells and securing public health protection for
the tens of thousands of people receiving human tissue and cell
transplants in the UK every
year.
I shall outline
the rationale behind the regulations and their expected benefits, main
provisions and impact on business. Human tissue and cells from both
living and deceased owners are transplanted in an
increasing range and number of procedures. One estimate undertaken a
few years ago concluded that some 10,000 patients a year benefit from
NHS treatments involving human tissue transplantation. That is now
thought to be a considerable underestimate of the current use of
tissues and cells. The British Association for Tissue Banking has
estimated that bone alone is used in 7,500 operations a year. In
2005-06, a total of 3,819 corneas were donated and 2,622 grafts were
carried out. Some 2,000 bone marrow transplants, 38,000 in vitro
fertilisation cycles and 7,000 donor insemination procedures are
performed annually, all of which will fall within the
regulations’
scope.
Systems are
already in place in the UK to improve the safety and
quality of tissue and cell transplantation. For example, in April 2001,
the UK health departments launched a voluntary accreditation scheme for
all tissue banks storing and processing human tissue for therapeutic
use in the NHS. Under the scheme, the Medicines and Healthcare products
Regulatory Agency inspected applicant tissue banks against the
voluntary UK code of practice for tissue banks, which requires tissue
banks to have appropriate facilities and to undertake staff training,
and establishes high standards for donor screening, process control and
record keeping. Similar standards are reflected in the
regulations.
For more than 15 years, the
Human Fertilisation and Embryology Authority has regulated the
fertility sector under the Human Fertilisation and Embryology Act 1990.
The HFEA is the UK’s independent regulator and oversees safe and
appropriate practice in fertility treatment, tissue storage and embryo
research. It licenses and monitors centres carrying out IVF, donor
insemination, storage and human embryo research and provides a range of
detailed information and guidance for patients, professionals and the
Government.
The
Human Tissue Authority was established to regulate the removal,
storage, use and disposal of human bodies, organs and tissue for a
number of scheduled purposes, such as transplantation, as set out in
the Human Tissue Act 2004. The Act covers England, Wales and Northern
Ireland; Scotland has separate legislation. Since 2006, the HTA has
licensed those establishments storing human tissue and cells for human
application.
The
regulations’ main benefit is that they will require all
establishments dealing with tissues and cells for human applications to
be regulated, ensuring that they meet high standards of quality and
safety. That will maximise the benefits for patients and minimise the
risks arising from infected, contaminated or poor quality tissues and
cells. It is proposed to require our two competent authorities, the HTA
and the HFEA, to regulate establishments carrying out procurement,
processing, storage, testing and distribution of human tissues and
cells intended for human applications such as
transplantation.
In
many respects, the provisions in the regulations will build on existing
legislation and guidance. However, in a small number of areas the
regulations will require the introduction of new provisions. For
example, all human tissues and cells intended for transplantation in
the EU will be traceable and will have to meet the same high standards.
Currently, apart from in the assisted reproductive sector, there are no
controls on the import or export of human tissues or cells. NHS or
independent-sector clinicians can import tissues and cells from
anywhere, controlled only by their own ethical duty to patients. The
regulations will regulate imports and exports of tissues and cells
imported from outside the EU, and will ensure that such tissues,
together with those supplied from within the EU, will be both of a high
standard and
traceable.
UK
infertility clinics are already regulated by the HFEA. However, few if
any other member states had so effective a system of regulation; in
fact, some had none at all. UK infertility clinics are licensed and
regularly inspected by the HFEA to ensure that they operate appropriate
practices that safeguard patient safety. In several areas, the HFEA has
already implemented measures similar to, or that serve the same purpose
as, the regulations. An example is the need for a system to report
adverse events or reactions and to disseminate lessons to other
establishments. There is a similar need for a “person
responsible” at each licensed
centre.
The HFEA and
the bodies that represent infertility clinics have worked together
during negotiation of the directive to agree appropriate practice
standards. They have fed into a new edition of the HFEA’s code
of practice, which will be laid before Parliament shortly.
Since 2006,
tissue and cell establishments that store human tissue and cells for
human application have been required to be licensed by the HTA under
the 2004 Act. Some 150 establishments and 118 satellites have been
licensed. In addition, to enable establishments to prepare for
implementation of the regulations, the HTA have made it a condition of
the licence that establishments meet the requirements of the first two
directives by April 2007 and work towards meeting the requirements of
the third directive, as reflected in the regulations.
The regulations set out the
requirement for a uniquely identifiable coding and labelling system for
human tissues and cells that will underpin both the traceability and
quality control of tissues and cells. An EU-wide coding system is being
developed to ensure that tissues, donors, tissue bank of origin,
processors and storage requirements can be instantly identified, no
matter where in the EU they originate from or are used. That will
eliminate confusion due to linguistic differences and enable rapid
recognition of tissues sent in error, thereby preventing the use of
suboptimal or unsuitable materials in human transplantation. This work
is being taken forward by the EU Commission together with
representatives of each member state, including the
UK.
The regulations
also require the introduction of a monitoring system for adverse
incidents and reactions to transplanted tissues and cells, and the
establishment of a system to monitor serious adverse events and
reactions. Such a scheme is in place for blood and blood products and
for the fertility sector through the HFEA. The HTA has developed an
online system for notification of serious adverse events and reactions,
and it is now operational. The establishment of a UK-wide system will
complement developments such as the National Patient Safety
Agency’s national adverse incident reporting system, and
increase public confidence in
transplantation.
Gametes
and embryos are within the scope of the directive and are therefore
included in the regulations. The regulations also extend the remit of
the HFEA to cover a range of treatments using a couple’s own
sperm. However, feedback to date from UK-licensed clinics and
professional bodies has broadly welcomed the regulations as a means
further to raise and maintain standards and best
practice.
The final
costs of implementing the regulations are set out in the regulatory
impact assessment. In summary, we estimate that set-up costs could be
in the region of £16 million to £18 million, with annual
recurring costs of approximately £4 million to
£11 million. They are divided between administrative and policy
costs.
Dr.
Andrew Murrison (Westbury) (Con): Will the Minister say
why the recurring costs are between £4 million and
£11 million? That is an extraordinarily wide margin. Why can the
Minister not be more specific?
Ms
Winterton:
It is quite difficult to give a definitive
cost because some establishments are up to a high
standard and some are not. While recurring costs might be in the margin
between say, £3 million and £12 million, the NHS
contribution will be up to a maximum of approximately
60 per cent. of that, which is around £7.5 million. We should
remember that costs will be divided between approximately 150 primary
care trusts, so the cost per PCT is fairly small.
Giving a definitive cost has
also been difficult because we have had to look at other health matters
such as blood products to see what changes would have to take place to
bring establishments up to standard. Certainly, costs fall within a
wide range. We have tried to be as flexible as possible in making an
estimate, but it has not been easy. When we look at the costs spread
across the NHS, we should recognise that the amount is not an undue
burden on individual PCTs. Also, the measure will raise quality and
standards across the whole sector.
Dr.
Murrison:
I accept that spread across the NHS, the burden
per PCT will be relatively small. The Minister has not, however,
explained to my satisfaction why there is such a wide
margin of error. What variables will impact on the question of whether
the costs will be toward the lower or upper end of the
margin?
Ms
Winterton:
As I said, the Government have tried to provide
as wide-ranging a measure as possible because it has been difficult to
look at every clinic or tissue bank individually and to say exactly
what systems are in place. An air conditioning system, for example,
might cost money to maintain over a period. That means that it is
difficult to say that the maximum costs will be X, Y or Z. In the
worst-case scenario, the costs to the NHS will be something like
£7.5 million spread between 150 PCTs, which is approximately
£50,000 per PCT. The regulations have been drawn up by involving
not only the NHS, but the independent sector, so people are well aware
that the changes are on the way and are prepared for them.
We have had to look at health
care areas in which similar systems are in place, to see what changes
might be necessary. It will of course be for individual clinics and
banks to satisfy us that they have the proper standards in place to
guarantee quality.
Norman
Lamb (North Norfolk) (LD): The regulatory impact
assessment deals with this question. It says that a sample of only two
units with widely divergent costs was used. Does the use of such a
sample make the assessment meaningless because of the divergence
between the two units? Would a sensible RIA—one that has some
meaning—have to have more information about the extent to which
units will have to raise their standards to meet the requirements of
the
regulations?
Ms
Winterton:
In drawing up the regulations, we tried to work
very closely with all the organisations concerned, whether from the NHS
or the private sector. Everybody agreed that these are the standards
that they wished to see implemented in the UK, so this cannot have come
as a surprise. We could have gone round all 150 centres and 118
satellites, but given that there is likely to be a range from the
current standard to the highest standard, we had to make an estimate
from that.
It has not been easy to go
around every single establishment. However, because we have consulted
widely, the regulations will not come as a surprise.
Individual PCTs and independent sector organisations will be well
prepared. It is also important to recognise that there will be
administrative costs. To a certain extent, those will depend on what
administrative support individual organisations might have in place and
on the additional testing requirements that there may be. We also know
that many establishments have already introduced the measures necessary
to comply with the regulations, so we do not expect a significant
impact on business in either the public or the private
sector.
I hope that we can all agree
that when we talk about issues such as fertility clinics and tissue
banks, it is important that people have confidence in the health
services. People have a right to expect high levels of protection in
terms of safety and quality. The regulations will impose very clear
standards of quality and safety for the donation, procurement, testing,
processing, storage and distribution of all human tissue and cells used
for any human application, including fertility procedures, across the
European
Union.
Mr.
David Burrowes (Enfield, Southgate) (Con): On the
processing and timing of the regulations, why was it appropriate to
follow through with the regulatory framework now—I appreciate
that there is the background to do so—rather than taking
advantage of the timing of the draft joint Bill, which is beginning to
make its way through Parliament, and using the primary legislative
route to consider the measure in
detail?
Ms
Winterton:
We are implementing a directive, and this
instrument is the procedure that is used. We could have waited, but
what is important is that we take advantage of the fact that we are
currently able to implement a lot of the changes already set out in the
regulations. We know that we have high quality and safety standards in
the UK. There are European Union deadlines to meet and it would be
unwise to wait until possible legislation when in fact, to meet the
deadline we need to get on and to do this now through what is a
generally accepted procedure in both
Houses.
Dr.
Evan Harris (Oxford, West and Abingdon) (LD): Will the
Minister give
way?
Ms
Winterton:
I was about to finish, but I will give
way.
Dr.
Harris:
My question relates to the point made by the hon.
Member for Enfield, Southgate. Had the timetable for the draft Bill,
the Bill, the new Bill and then the draft Bill not
slipped—because the consultation had slipped—would the
Government have used primary legislation as a way of implementing the
regulations? Was the intention always to use section 2 of the European
Communities Act
1972?
Ms
Winterton:
It was always our intention to do it
like that, it being the quickest and most effective way to implement
what are fairly uncontentious
regulations.
4.50
pm
Dr.
Murrison:
: It is a pleasure to serve under your
chairmanship, Mr. Chope.
I am grateful to the Minister
for her extensive description of the regulations. Again we find
ourselves using parliamentary time to rubber-stamp directives over
which we have little control. However, that may not detract from their
quality. The right hon. Lady was bullish in extolling the virtues of
this set of regulations which, as she says, deals with quality. I am
pleased that she underscored the quality that we enjoy in this country
in respect of the handling of human tissues. She and I debated such
matters at some length in the not too distant past when we discussed
the Human Tissue
Bill.
The guidance
notes say that most requirements in the directive are not new to
licensed institutions or that they are established good practice. That
gives rise to the question as to why we need them at all in such an
extensive form. Both sets of guidance notes state:
“Regulations do address
other areas not currently covered by the 1990
Act”
and the Human Tissue
Act 2004. I listened carefully to the Minister and the only issue that
I could pick out that was not already covered by the Human Tissue Act,
in particular, was the need for traceability. Will she explain what
other aspects surrounding the handling of the material in the United
Kingdom need to be addressed by the regulations and what quality they
will add?
We could be
worried about other countries. If so, I invite the Minister to say
which particular countries she thinks have a particular problem. What
pressure will be brought to bear on those countries to ensure that they
come up to speed and emulate the quality to which she referred? How
long will it be before the directives are implemented fully throughout
the European economic area? If we are worried about standards abroad,
what is the status of non-EU countries with which we exchange material?
What proportion of material exchanged is UK, European Union and non-EU
sourced? Clearly, that is
important.
The
Minister spent some time describing how many procedures are carried
out. An extensive list of procedures involve human tissue, but she did
not explain what proportion of those procedures were performed using
material from various sorts. If tissues, gametes and embryos must be
marked with an EU-wide coding system, what are the implications for
non-coded, non-EU
material?
On 14 May
2007, Lord Hunt said that the
“imports and exports of tissues
and cells imported from outside the
EU”—[Official Report, House of
Lords, 14 May 2007; Vol. 693, c.
95.]
will
ensure high standards and traceability. Paragraph 15 of the Human
Tissue (Quality and Safety for Human Application) Regulations 2007 does
indeed allow for licence holders to be obliged to ensure that the
imports of tissues and cells from non-EEA states meet the same
standards of quality and traceability as those for EEA countries.
However, I could not find a similar requirement in the Human
Fertilisation and Embryology (Quality and Safety) Regulations 2007.
Presumably neither of them will have to comply with the EU-wide coding
system, which in any case is still under development.
I hope that the Minister can
explain how non-EEA material will be managed under the Human
Fertilisation and Embryology (Quality and Safety) Regulations or point
to some other regulations that will guarantee the traceability and
quality of gametes and embryos. Without such a guarantee, the
regulations could have a paradoxical effect, because there is the
potential for less desirable non-EEA material to be favoured by clinics
eager to exploit a loophole. Can she say how the Human Tissue Authority
will ensure that licensees apply the same standards to human tissue
from non-EEA states and from EEA countries? The trafficking of human
tissue is a scandal and I am especially keen to learn how these
regulations will reduce the likelihood of EU countries, particularly
the UK, becoming involved.
We learn that traceability data
must be kept for 30 years. How has the Minister chanced upon
30 years? When questioned by Earl Howe in the other place on 14 May,
Lord Hunt did not seem to know why 30 years had been chosen. If we are
worried about the transfer of prions, for example, who can say whether
30 years is long enough? It will be interesting to know what extra cost
would be involved if that 30 years were extended, say, to 40 or 50
years. The regulations create a single regulatory framework for
reproductive and non-reproductive tissue banking, which paves the way
for the merger of the HFEA and the Human Tissue Authority. I reiterate
Earl Howe’s observation to the effect that we reserve judgment
on the desirability of that merger.
The Minister has said that
compliance will cost between £16 million and £18 million,
with recurring costs of between £4 million and £11
million. I am still not clear why we have such a wide margin for
recurring costs. I accept her assertion that for the NHS that boils
down to a “mere” £50,000 per primary care trust. I
do not know about the Minister’s PCT, but mine would rather
resent the implication that £50,000 is a mere bagatelle. Does
she accept that, given the disproportionate cost of regulation on small
enterprise and her Department’s admission that practice is
already good in the UK, the 80 per cent. of infertility clinics that
are classified as small firms will be disproportionately affected by
that?
According to
Lord Hunt, 11 organisations have already decided not to register under
the regulations. What reason can the Minister come up with for that? Is
it cost? Have they shut up shop completely or have they moved away from
the European Union in order to avoid them?
4.59
pm
Norman
Lamb:
It is a pleasure to serve under your chairmanship,
Mr. Chope. I will keep my remarks brief. I am sure that the
Committee will be pleased to hear that I want to ensure that my hon.
Friend the Member for Oxford, West and Abingdon has an opportunity to
contribute to the debate as well. However, I want to make it clear at
the start that the measures are uncontroversial and we support them. I
am grateful to the Minister for having set out their extent with such
clarity.
It makes
sense for there to be EU-wide standards in this area, but the hon.
Member for Westbury started
his remarks by casting doubt on the fact that Europe was legislating in
this area. It makes absolute sense for Europe to legislate so as to
ensure that there are common standards across the
EU.
Dr.
Murrison:
I tend to agree with the hon. Gentleman so long
as the majority of transfer happens between EU member states rather
than within the UK or between the UK and non-EEA
countries.
Norman
Lamb
I am grateful for that intervention. The hon.
Gentleman raised some reasonable concerns about activities beyond the
EU. I wanted to ask questions on those points, which none the less do
not seem to diminish the case for EU-wide standards. I know that my
hon. Friend the Member for Oxford, West and Abingdon may want to raise
some questions about the extent of the application of the regulations;
I shall leave that to him.
In commenting on the position
throughout Europe, the Minister suggested that the UK had been well
ahead of the rest of Europe in regulating standards in this area. I
absolutely accept that. The Department’s helpful guide makes the
point that the directive was to be implemented throughout the rest of
the EU by 7 April last year, so it has been in force for more
than a year. Will the Minister provide an update on the position
throughout the EU? Has the directive been implemented in accordance
with the requirement, or does she anticipate infraction proceedings
against a number of countries? I heard a Labour Member refer to Greece
in the context of countries with which there may be problems over
standards. Will she confirm whether there are concerns about any
particular EU countries, particularly Greece?
The hon.
Member for Westbury raised concerns about matters beyond the EU. Are
there concerns about standards not being sufficiently high in
particular jurisdictions from where a significant proportion of supply
comes? The guidance notes refer to the fact that the regulations will
cover the emerging internet market, which is notoriously difficult to
regulate. Does the Minister have any observations on whether she
regards that as an area of concern that needs attention to ensure
sufficiently high standards, particularly given that the sourcing may
well be beyond the EU?
The Minister responded to
interventions on the wide range of ongoing costs of applying the
regulations. I was concerned at the implication of the comment of the
hon. Member for Westbury that there may be a disproportionate impact on
small firms. It is self-evident that the standards have to apply to all
clinics and units, irrespective of size. The point is to ensure that
the regulations do not go beyond what is necessary to ensure high
standards. Once we have established what is necessary, however, that
has to apply across the board, irrespective of the size of the
organisation, even if that has a disproportionate effect on smaller
companies.
Dr.
Murrison:
Of course, standards have to apply equally to
firms of all size. The point that I was trying to make was that, in the
regulatory impact assessment,
it is necessary to consider the impact of regulation on all parts of the
economy. It is a pity if the hon. Gentleman was trying to twist my
meaning.
Norman
Lamb:
I certainly was not trying to twist the hon.
Gentleman’s meaning. Once one establishes the necessary
standards, they have to apply across the board, even if they have a
disproportionate effect on smaller firms. The regulatory impact
assessment assesses the total benefit that we can expect from the
regulations. It gives a figure of £9 million, but it makes it
clear that that is, in effect, a stab in the dark. Is the Minister
confident that it is a reasonable estimate of the potential benefits,
or could she give us more guidance? Those are the questions that I
wanted to put to the Minister. Overall we accept the purpose of the
regulations and are happy to support
them.
5.5
pm
Dr.
Harris:
I just have a couple of supplementary questions to
those put by my hon. Friend on the internet supply of sperm services
and related matters. I am not sure whether it is squeamishness on the
part of other members of the Committee that this issue has not been
raised so far. As the Minister well knows, the greatest interest has
been in the extension of regulation to the use of fresh gametes for
commercial purposes such as by the “ManNotIncluded”
website and similar provisions. I also want to raise a question about
the impact of the welfare of the child clause and its inter-relation
with these regulations and with the draft Bill on human tissue and
embryos.
In relation
to fresh gamete services, my understanding is that the Human
Fertilisation and Embryology Act 1990 applies only to gamete services
that involve the storage of sperm as well as the creation and storage
of embryos. The idea behind unregulated services such as
“ManNotIncluded” is that women can get fresh gametes for
self-insemination without there being a storage phase. The
Government’s view was that the directive requires those services
now to be regulated and I do not dispute that. My question to the
Minister is whether the Government have an understanding of where the
line will be drawn.
A
company that advertises a commercial service of fresh gamete supply for
the purposes of insemination or any other purpose would be covered, but
would a non-commercial operator also be covered? My reading of the
regulations is that it would because gametes are being procured. If so,
what is the status in law of the quite well known very informal
arrangements between individuals in this country who use a
friend’s gametes for self-insemination in order to overcome
fertility issues? [Interruption.] I notice that there is
giggling on the Front Benches, but it is an important issue.
Many lesbian couples use a gay
man’s sperm in order to avoid the humiliation
of being turned down for treatment services under the 1990 Act with its
discriminatory provision of having regard to the need of the child for
a father. The Government, in their draft Bill, have accepted that that
is discriminatory under their own Equality Act (Sexual Orientation)
Regulations on the provision of goods and services. That is a commonly
used scheme. If
the authorities find out, will those using it be committing an offence?
It is an important question for people outside this Committee and I
hope that the Minister will be able to answer
it.
My second question
is only somewhat related. Basic treatment services are now going to be
included in the provisions. I note from the very helpful document that
the Minister provided, which sets out what the HFE Act will look like
with these new regulations, that the welfare of the child provision, in
its unamended form with the discriminatory provision about having
regard to the need of the child for a father, will now even apply to
basic treatment services. Section 13(5)
states:
“A
woman shall not be provided with treatment services, other than basic
partner treatment services, unless account has been taken of the
welfare of any child who may be born as a result of the
treatment”.
In that
transposition, it appears that basic partner treatment services are not
subject to that provision. But paragraph 105 on page 106 of the
explanatory notes to the draft Bill states:
“The power under which
the regulations implementing the EU Tissue Directive are to be made
(section 2(2) of the European Communities Act 1972) is not regarded as
giving power to apply the welfare of the child provisions in section
13(5) of the 1990 Act to the provision of basic partner treatment
services as defined in the 1990 Act as amended by the regulations.
Clause
20(2)(a)”—
of the
draft Bill; it is actually clause
21(2)(a)—
“amends
section 13(5) so that it does apply to the provision of basic partner
treatment
services.”
Could the
Minister explain what is meant by “basic partner treatment
services”?
I
understand that if the draft Bill is passed, the need-for-a-father
provisions will be got rid of, but if the basic partner treatment
services are also to be subject to a welfare-of-the-child test, it is
important that the Minister explains what they are, and why a series of
further couples will be subject to a discriminatory provision where
they have to show their suitability as parents in a way that
non-infertile people do not need to
do.
The Minister will
be aware that there is controversy within the welfare-of-the-child
discussions even without the need-for-a-father provisions. It would be
helpful to know what she means by basic treatment services in that
regard. If she can deal with those two questions, I will be happy to
leave it
there.
5.11
pm
Ms
Winterton:
I shall start by addressing some of the
issues around other member states and how long it may take them to
comply with the directive. We do not have data on other member states.
As I said, in this country, we still have an advantage because we have
very high standards and thus have a head start.
The European Commission is
carefully monitoring compliance and it is already clear that it is
prepared to begin infraction proceedings if any member state fails to
implement the directive or to delay implementation unduly. We have made
it clear that if we have any worries about other member states not
complying, about the quality of tissue and so on coming into the UK, or
about clinics using sub-standard material or material that has not been
kept to the high quality that
we would want, it is up to the HFEA to tell the clinic that it should
not accept the material. We would, if necessary, go to the European
Commission if problems were caused in individual member
states.
Norman
Lamb:
Is the Minister aware of any particular areas of
concern at present, either within the EU or
beyond?
Ms
Winterton:
We are not aware of any concerns at the
moment, but the regulatory authorities are keeping an eye on the
matter. In this country, we have a lot of experience in knowing how to
ensure that standards and quality are high because we have already set
up regulatory bodies. The labelling and coding that will follow from
the regulations will be an important part of ensuring that we can
monitor the quality of imports.
Mr.
Kevan Jones (North Durham) (Lab): I give the Minister an
example, although it does not relate to embryology tissue. My
constituent Christopher Rochester died five years ago on the island of
Rhodes. One of his kidneys was removed for unexplained reasons, and
some two years later it was returned to the UK, where it was discovered
that the kidney was not his. The Greek authorities deny that, and there
is a protracted legal dispute about it. My experience of dealing with
the Greek authorities on the transfer of human tissue, in this case a
kidney, is very poor.
Ms
Winterton:
My hon. Friend brings me neatly to the issue of
traceability. Hon. Members asked about the figure of 30 years and I can
reassure the Committee that no specific factor determined why the
30-year figure was chosen. It was arrived at by negotiation between the
member states, as it is likely that patients could develop medical
conditions that might be related to the use of transplanted tissues and
cells many years after the transplant took place. Thirty years was
considered to be an appropriate amount of time to retain such records
to assist diagnosis of such conditions and, if necessary, to ensure
that the tissue donors can be traced, should there be any medical
implications for them.
My hon. Friend is right to draw
attention to the importance of considering such issues and why it is
important to have a European-wide approach on safety
issues.
Mr.
Jones:
I totally agree with a European-wide regulation for
tissue but the problem is that that does not mean anything in practice
in Greece and certainly not on the island of Rhodes. The Greek
authorities are still, in this case, disputing the facts, even though
the kidney that I mentioned was DNA-tested in this country and found
not to be the kidney of my constituent; obviously it is the kidney of
some poor Greek citizen. They are refusing to accept that kidney back
or explain to the family what has happened to the original kidney.
Although I agree with my hon. Friend about European-wide jurisdiction,
I am not sure that it addresses what happens in
practice.
Ms
Winterton:
I am sure that all members of the Committee
would agree that we are trying to improve the current situation so that
it is much more reliable.
I shall briefly answer a number
of the questions that were asked. First, in terms of the points made by
the hon. Member for Oxford, West and Abingdon, about the welfare of the
child, these directives cover safety and quality and do not venture any
further. He was referring to other legislation, which is not covered by
these regulations. If I can illuminate him by writing to him about the
cross-over with other legislation, I shall be more than happy to do so.
However, I wish to make clear that these regulations simply talk about
the safety and quality of storage, and knowing where the tissues and so
on come
from.
Dr.
Harris:
I accept that I was not perhaps as clear as I
should have been. These regulations insert basic partner treatment
services into section 13 of the 1990 Act, with the intention,
declared later on, that those will then be covered by the
welfare-of-the-child provision, albeit that the regulations do not
allow the Government to carry out their declared intention to ensure
that the welfare-of-the-child test is applied to that. Those basic
partner treatment services include non-gamete, non-embryo services,
which do not involve sperm or embryos at all. Patients who may need
hormonal treatment will be subject to that discriminatory test about
whether they will be good parents in a way that most other parents are
not. What is the justification for inserting that in that section? The
Minister did not have to issue the regulations, so why is she doing
so?
Ms
Winterton:
As I have said, the regulations follow on quite
long periods of negotiation and consultation with all interested
parties. In a sense, the different provisions have been inserted, not
with the purpose of creating a hook to other legislation, but because
of the purposes of the directive itself—to ensure high quality
and safety.
I move now
to the new areas about which the hon. Gentleman asked. Obviously, there
is not only the traceability, but the reporting of serious adverse
events and the sperm testing processors. There is artificial
insemination using the partner’s own gametes, and there is also
internet sperm delivery.
I would like to expand a little
on the internet sperm delivery proposals. Currently, internet sperm
delivery is not subject to regulation, so patients must take the
supplier’s word on testing and so on. However, internet sperm
providers will now be subject to the same regulatory requirements as
clinics providing donor sperm, so that patients can now be assured that
the sperm that they receive is safe. Those are some of the new
procedures that will be covered.
Dr.
Murrison:
The Minister mentioned sperm testing procedure
and I simply do not know what she has in mind; perhaps she could inform
me.
Ms
Winterton:
It is a series of tests to ensure that the
sperm is safe and that it has been properly stored and is of high
quality.
With regard
to non-EU countries, I can assure the Committee that clinics will need
a licence to import from non-EU countries and that
the licensers will require them to meet similarly high standards. Of
course, the
HFEA Act already regulates imports from non-EEA countries, with clinics
needing the permission of the HFEA.
On the subject of fertility
clinics that are closing, I think that there have been about 11
closures, for various reasons; some closures are connected with the
clinics still trying to get an IVF licence. Four of the 11 clinics that
have closed did not give a reason for closing. However, we must be
absolutely clear that what we are trying to do here is to ensure that
there are high standards of quality and safety. If, to a certain
extent, some clinics do not feel that they wish to meet those
requirements, we must be absolutely clear that we must think of the
patients, the people using these clinics. We must send a clear message
that we expect high quality maintenance of supplies.
As I have said, there has been
widespread consultation on these regulations over a number of years.
There is general agreement that we are taking the right approach to
safety. We must accept that, if some people do not wish to go along
with that approach, that is absolutely up to them. However, I believe
that it is our job to say what we expect in terms of
delivery.
Dr.
Harris:
I am satisfied with the Minister’s answer
to one question, but I raised the issue of those people who are not
using internet providers of gametes, but are just using gametes
provided by a friend. It seems that the definitions in the measure go
more widely than the internet; they do not mention the internet. As far
as I know, they do not use the words “commercial” or
“professional”, although I may be wrong about that.
Therefore, I am seeking guidance from the Minister as to whether the
hundreds of people who make private arrangements to have supply of
fresh gametes for purposes of insemination will be covered by the
regulations. I would be grateful if she could at least let me know
whether she can write to me if she cannot answer what I thought was a
question that would have been anticipated
today.
Ms
Winterton:
These regulations will not affect those private
arrangements. As I have said, what we are discussing here is, in many
cases, what is provided by clinics in terms of the human tissue, safety
and storage. It is not feasible to cover the other issues.
As I have said, we should
generally welcome these regulations, which will provide for higher
quality in the services given to patients and ensure that there is
greater degree of confidence among service users and that reliable and
high standards exist both across and outside the EU. I commend them to
the Committee.
Question put and agreed
to.
Resolved,
That
the Committee has considered the draft Human Fertilisation and
Embryology (Quality and Safety) Regulations
2007.
Resolved,
That
the Committee has considered the draft Human Tissue (Quality and Safety
for Human Application) Regulations 2007.—[Ms
Winterton.]
Committee
rose at t
wenty
-
six minutes past Five
o’clock.
